Reducing the testosterone levels of existing intersex female athletes is unfair and unjust.

The term intersex covers a range of conditions. While intersex athletes have raised levels of testosterone, its effect on individual performance is not clear. Some disorders which cause intersex change the way the body responds to testosterone. For example, in Androgen Insensitivity syndrome, the testosterone receptor may be functionless or it may be partly functional. In the complete version of the disorder, although there are high levels of testosterone present, it has no effect.

As we don’t know what effect testosterone has for these athletes , setting a maximum level is sketchy because we are largely guessing from physical appearance to what extent it is affecting the body. It is not very scientific. We simply don’t know how much advantage some intersex athletes are getting even from apparently high levels of testosterone. Continue reading →

Chinese researcher Jiankui He of Shenzhen claims to have gene edited two healthy embryos, resulting in the birth of baby girls born this month, Lulu and Nana. He edited a gene to make the babies resistant to HIV. One girl has both copies of the gene modified while the other has only one (making her still susceptible to HIV).

On July 29, 2017, He uploaded a copy of his lecture on YouTube, “Evaluating the safety of germline genome editing in mouse, monkey and human embryos“. He finishes the lecture (see 11:22) arguing that experimentation in humans should be “slow” and with “caution”, remarking that “a single case of failure might kill the entire field”, as in the case of the death of Jesse Gelsinger. He closes with a picture of Gelsinger.

Gelsinger died during a somatic (not germline) gene therapy trial nearly 20 years ago. Early gene therapy trials were conducted with an emphasis on participant consent. A somatic cell gene therapy was developed for ornithine transcarbamylase deficiency, a disorder of nitrogen metabolism. The condition comes in two forms: mild, with normal life expectancy and management by diet, and severe, which is lethal in the first year. Researchers, acting on the advice of ethicists, decided to conduct the first trials in adults with the mild form of the disease as they were capable of consenting. Gelsinger consented at age 18 and died due to a catastrophic immune reaction. He would have had a normal life expectancy in the absence of the intervention.

At the time, I wrote this paper. I argued the main failing of that experiment was failure to minimise expected harm. The design of the trial was flawed; it should have been conducted in infants with the severe form of the disease, as this would have resulted in less expected harm.

If true, this experiment is monstrous. The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer. There are many effective ways to prevent HIV in healthy individuals: for example, protected sex. And there are effective treatments if one does contract it.

This experiment exposes healthy normal children to risks of gene editing for no real necessary benefit.

It contravenes decades on ethical consensus and guidelines on the protection of human participants in research.

In many other places in the world, this would be illegal punishable by imprisonment.

Could gene editing ever be ethical? If the science progressed in the future and off target mutations reduced to acceptable and accurately measurable level, it might be reasonable to consider first-in-human trials (with appropriate safeguards and thorough ethics review) in one category of embryos: those with otherwise lethal catastrophic genetic mutations who are certain to die. Gene editing for this group might be life-saving; for these current babies, it is only life-risking.

These healthy babies are being used as genetic guinea pigs. This is genetic Russian Roulette.

This week the Australian Senate will debate a private members’ bill that will consider whether to overturn the 21-year-old Euthanasia Laws Act that nullified the ability of Australian self-governing territories to pass legislation in relation to euthanasia and assisted suicide.

The deliberation on whether to continue the arbitrary over-riding of the territories’ legislative autonomy in this domain will inevitably also turn a spotlight on the judiciousness of Victoria’s recent voluntary assisted dying legislation that empowers terminally ill people who are residents of our state and who are experiencing unrelievable suffering, to end their lives on their own terms.

Standing firmly and resolutely against such legislation is Professor Margaret Somerville, from the University of Notre Dame, who was interestingly described in an article in the Sydney Morning Herald two days ago as having “spent decades observing euthanasia in Canada”, even though medically assisted dying only became legal in that country in 2016.

One of the concerns she has raised is the “slippery slope” to unethical assistance in dying. Currently, this might well be on people’s minds because of the reports of the deaths of three minors during 2016-2017 as the result of euthanasia in Belgium, out of 4337 deaths during that period. The deaths of the under-18-year-olds occurred as a result of the removal of age limits on access to euthanasia in Belgium that took place as a result of legislation introduced in 2014, 12 years after the introduction of euthanasia for adults.

In contrast to Belgium (which is the only jurisdiction that places no age restrictions on euthanasia or assisted dying), the Victorian Parliament passed the Voluntary Assisted Dying Act in November last year, which limits voluntary assisted dying (VAD) to terminally ill people 18 years and older, who fulfil very strict criteria in relation to experiencing unrelievable suffering and possessing sufficient decision-making capabilities. They must be in the last six months of life, unless they’re suffering from a neurodegenerative disease, in which case they must be in the last 12 months of life.

There are many reasons that both the Victorian Legislative Council’s Inquiry into end of life choices and the Ministerial Advisory Panel on Voluntary Assisted Dying recommended limiting VAD to adults, including the fact that the extensive consultations with the Victorian public led to the firm conclusion that, as stated in the inquiry’s final report: “Victorian values do not support allowing assisted dying to be provided to those who are yet to reach adulthood.”

Consider a hypothetical version of a real life disease, Gaucher’s Disease. Gaucher’s disease is an inherited disorder caused by a genetic mutation. The mutation means an enzyme– glucocerebrosidase — is not produced. A a result, glucerebrosides (fats) build up, damaging cells. This can cause bone fractures, liver enlargement, and bleeding but most importantly, brain damage. Once this has occurred it is irreversible.

Enzyme Replacement Therapy (ERT) is now available and for the purposes of this hypothetical case, the treatment offered, if given from the moment of birth, will prevent all damage (in real life current enzyme replacement treatments do prevent most symptoms, but do not affect nervous system involvement).

In our hypothetical case, a child is born to parents known to carry the mutation for Gaucher’s Disease, and prenatal testing has already confirmed that the baby is affected. ERT must be started at birth in order to prevent brain and other damage. However, the parents are Christian Scientists and refuse medical treatment. They believe prayer can cure their child’s condition.

Doctors are concerned the missing enzyme needs to be replaced before the child’s brain is damaged. They take the case to court where judges agree that therapy is in the child’s best interests.

Womb transplants are again in the news as Richard Paulson, president of the American Society for Reproductive Medicine (ASRM), said there was no reason to believe that the treatment could not work for transgender women at recent conference in Texas.

The ethical issues of performing a womb transplant for a transgender women are substantially the same as the issues facing ciswomen.

The most important ethical consideration in the UK for a womb transplant is distributive justice. Limited health care resources should not be used for womb transplants because there are more cost effective methods of assisted reproduction available. However if an individual wishes to use their own funds for such a procedure, they should be made aware of the risks (which are very significant), and the alternatives, such as surrogacy.

The best interests of the future child is another critical consideration. The moral status of the fetus is a topic of much debate. However, even if we consider abortion to be acceptable, and deny that the fetus has a moral status that accords it its own interests, in cases where the mother plans to carry the pregnancy to term, the fetus represents the future child who does of course have interests (albeit that they are to be weighed against the mother’s own interests, and that the mother is responsible for making decisions on their behalf).

Blade Runner 2049, like the original, is about identity, humanity and discrimination.

Identity and Humanity

In both films, bioengineered humans are known as replicants. Blade Runners “retire” or kill these replicants when they are a threat to society. In the original, Blade Runner Rick Deckard (Harrison Ford) has all the memories and feelings of a human and believes himself to be a human, only at the end to discover he is a replicant. In the sequel, K (Ryan Gosling) is a replicant but comes to believe (falsely) that he is Deckard’s child. In Blade Runner 2049, we are left to watch K dying, realising his memories were implanted by Deckard’s daughter.

In both films we are left wondering what difference there is between a human and a replicant. In the original, rogue replicant Roy Batty (Rutger Hauer) saves Deckard’s life (as Deckard was trying to kill him) and delivers famous “Tears in the Rain” speech:

“I’ve seen things you people wouldn’t believe. Attack ships on fire off the shoulder of Orion. I watched C-beams glitter in the dark near the Tannhäuser Gate. All those moments will be lost in time, like tears in rain. Time to die.”

Roy comes across as more human than the humans in the film. Indeed, in a preceding scene, a thorn or spike appears through his hand reminiscent of Christ, whose own identity as fully human and fully divine has puzzled Theologians for two millenia.

Both films challenge what it is to be human. In 2049, K believes the child of Deckard might have a soul because it was born.

Who are we?

The films both raise fundamental questions about personal identity: who are we? What fundamentally defines the existence of a person from one moment to the next? In both films, there is the suggestion that the biological mass, the body, is not what matters but the mind. In the original, bioengineered Roy seems as human as Deckard, as human as someone could be. In 2049, the idea is extended further still: K’s girlfriend Joi is an AI but seems as real as the other characters and her death is equally tragic.

Derek Parfit died in January this year. He was the world’s most famous moral philosopher (and his favourite film was another Ridley Scott classic, The Duellists). One of his famous ideas is that “identity” is not what matters. He articulated this in his masterpiece, Reasons and Persons (Oxford: Clarendon Press, 1984). According to Parfit, what matters is psychological continuity and connectedness, that is, the unity of our mental states.

Donald Wills is a self-made man. He is billionaire British banker who has taken an interest in technology. He believes the Singularity is near and wishes to live as long as possible. He completes an advance directive to use his money to keep him alive at all costs, should he become ill and unable to express his wishes. He tells his wife about these desires.

Donald develops a rare condition where the mitochondria in all his cells stop working. The mitochondria are power packs for every cell. Donald’s muscles stop working and he is admitted to a famous London hospital and has to be put on a breathing machine. His brain is affected- he suffers fits which need to be controlled by medication. There is no known cure and he is going downhill.

Doctors call in his wife and explain his dismal prognosis. “It is,” they say, “in his best interests to stop this burdensome treatment in intensive care. He will never regain normal brain function but he is conscious at times and feels pain. He should be allowed to die with dignity.” After all, Donald is 75.

Charlie Gard should have been allowed to go to US for experimental treatment back in April (or better January when it was first considered) because there was some possibility of him having a life worth living after treatment. That possibility may have been slim, but it does not appear (to us) to have been zero. The rational strategy was to give a trial of treatment, say 3 months, and agree with family to withdraw ventilation if there was no improvement. If this had been done, we would now have some information on whether there is any prospect of improvement..

The critical quote in the judgment of Justice Francis in the High Court back in April is from the independent US expert in nucleoside replacement therapy, Dr I:

“He said that he thought that the treatment, if administered, was unlikely to be of any benefit to Charlie’s brain. He described the probability as low, but not zero.”

Dr I said that if Charlie were his patient, he would push for a trial of treatment.

Is 3 months of suffering associated with intensive care worth taking for, say, a 1/10 000 of improvement? This is a value judgement about which there is reasonable disagreement. Sadly, Charlie has experienced the pains and discomforts of intensive care for more than six months, now without any treatment with any prospect of improving his condition.

The state should not have to pay for expensive experimental treatment with low prospect of success but Charlie’s parents have raised the funds. Charlie should have been allowed to go straight away (and saved hundreds of thousands of pounds of scarce British taxpayer funds which have been used to provide months of intensive care) provided a reasonable physician would treat him in the US. Dr I appeared to be a reasonable and responsible physician.

This is not a religious or right to life argument, or an argument based on compassion. It’s a secular ethical argument about the extreme complexity of judging someone’s life to be not worth living, or judging the prospects of having a life worth living to be not worth taking. The courts have deferred to one group of doctors who are experts in the facts, but they are not experts in the ethics.

More than six months have passed since experimental therapy was first considered. We don’t know how bad Charlie’s brain damage is now. Whether experimental therapy is still warranted depends on whether there remains any prospect of any meaningful life, and how that should be balanced against further intensive care. Perhaps the moment has passed.

The tragic case of Charlie Gard has captured the imagination of social media, the Pope and President Trump. All of Charlie’s legal options appear to have been exhausted so, despite the tsunami of opinion, it looks like treatment will be withdrawn, barring some act of God or other authority.

I argued back in April and then inMay that it would be reasonable to give Charlie a trial of experimental treatment for a fixed period, say 6 months. The treatment was not going to make him worse and there was a non-zero possibility of some improvement. At the end of 6 months, his progress could have been reviewed and a decision then made to withdraw treatment if no significant progress had been made. I argued that we can’t be certain that his life is not worth living and we can’t be certain treatment will lead to zero improvement. I argued that the costs – 6 months of sedation and analgesia, with limited amounts of suffering associated with medical procedures, was arguably worth taking. That course was not taken.

Worst of All Possible Worlds

Charlie was born in September 2016. He was admitted to hospital in October. By January 2017, his mother had identified an experimental treatment (nucleoside replacement therapy) available in the US.

By April 2017, the Gards had crowd-sourced £1.2million to take Charlie to the US for experimental therapy. However, a judge ruled life is not in his best interests. He must die. Numerous appeals were lodged, and lost, all the way up to the European Court of Human Rights. Now the Pope and President Trump have weighed in.

It is now over 6 months since Connie Yates , Charlie’s mother, identified and petitioned for an experimental treatment. During the whole of that time, Charlie has been ventilated in intensive care, receiving no therapy offering any prospect of improvement. If treatment had been started back in January, immediately, we would now have evidence presentable to the family, courts, media and doctors of whether it was yielding any improvement, or not.

Unless the treatment itself would have serious side-effects, or was expensive, there is no downside to it being provided, especially when Charlie is being kept alive anyway. Since the parents had raised funds to provide it themselves, there is no justice or resource allocation issue.

Not providing the experimental treatment at the outset is the very worst situation for everyone:

Charlie has been kept alive since January, suffering the alleged harms of intensive care, without receiving an intervention that might lead to an improvement.

His parents have had to watch their child being kept alive, without receiving the treatment they hope will have some effect.

Doctors have had to keep alive a child for 6 months whom they believe is suffering and should die with dignity.

Courts and the family have been denied real time real life information about whether the intervention does have any effect. They have been forced to make non-evidence based decisions.

The reasonable course of action, given the time taken by the court process, would have been to immediately start nucleoside replacement therapy at the parents’ cost (if justice precludes stricken NHS funds being used for it), while petitions to court were made to withdraw active treatment. That would have meant we would have more information about what 6 months of therapy might be able to achieve, and Charlie would have been given his fair go. It would be a better position to be in for all concerned.